Generic Name: romidepsin (ROE-mi-DEP-sin)
Brand Name: Istodax
Romidepsin is used for:
Treating cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) in certain patients.
Romidepsin is a histone deacetylase (HDAC) inhibitor. It works by killing sensitive cancer cells.
Do NOT use romidepsin if:
- you are allergic to any ingredient in romidepsin
- you are taking clarithromycin, halofantrine, nilotinib, St. John's wort, or toremifene
Contact your doctor or health care provider right away if any of these apply to you.
Before using romidepsin:
Some medical conditions may interact with romidepsin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have abnormal potassium or magnesium levels in your blood
- if you have a history of liver or kidney problems, or irregular heartbeat (eg, QT prolongation, congenital long QT syndrome) or other heart problems
- if you have nausea, vomiting, or diarrhea
- if you have had chemotherapy treatment in the past
- if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Some MEDICINES MAY INTERACT with romidepsin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by romidepsin
- Antiarrhythmics (eg, amiodarone, propafenone, quinidine), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, iloperidone, macrolide antibiotics (eg, erythromycin, clarithromycin), maprotiline, methadone, nilotinib, paliperidone, pentamidine, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin), tacrolimus, terfenadine, tetrabenazine, toremifene, tricyclic antidepressants (eg, amitriptyline), tyrosine kinase receptor inhibitors (eg, dasatinib, sunitinib), or ziprasidone because the risk of severe and possibly fatal irregular heartbeat may be increased
- Azole antifungals (eg, ketoconazole, voriconazole), boceprevir, HIV protease inhibitors (eg, atazanavir), nefazodone, telaprevir, or telithromycin because they may increase the risk of romidepsin's side effects
- Carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John's wort because they may decrease romidepsin's effectiveness
- Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by romidepsin
This may not be a complete list of all interactions that may occur. Ask your health care provider if romidepsin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use romidepsin:
Use romidepsin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with romidepsin. Talk to your pharmacist if you have questions about this information.
- Romidepsin is usually given as an injection at your doctor's office, hospital, or clinic.
- Do not use romidepsin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- If you miss a dose of romidepsin, contact your doctor right away.
Ask your health care provider any questions you may have about how to use romidepsin.
Important safety information:
- Nausea, vomiting, and loss of appetite are common with romidepsin. Ask your doctor or pharmacist for ways to decrease these effects if they occur.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Romidepsin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Romidepsin may lower the ability of your body to fight infection. Infections can occur during treatment and within 30 days after treatment has stopped. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- A serious and possibly fatal condition called tumor lysis syndrome (TLS) has occurred infrequently in certain patients taking romidepsin. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
- Diabetes patients - Romidepsin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using romidepsin. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Lab tests, including complete blood cell counts, blood electrolyte levels, and electrocardiograms (ECGs), may be performed while you use romidepsin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Tell your doctor or dentist that you take romidepsin before you receive any medical or dental care, emergency care, or surgery.
- Romidepsin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Romidepsin may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using romidepsin while you are pregnant. It is not known if romidepsin is found in breast milk. Do not breast-feed while you use romidepsin.
Possible side effects of romidepsin:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; fatigue; headache; loss of appetite; nausea; stomach pain; taste changes; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, tenderness, swelling, or redness; chest pain; decreased urination; fainting; fast or irregular heartbeat; mental or mood changes; muscle weakness, cramps, or spasms; seizures; severe or persistent dizziness, nausea, vomiting, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; swelling of the hands, ankles, or feet; swelling, soreness, or redness of the mouth or tongue; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; weakness; unusual drowsiness; confusion; rapid breathing; flushing; fruit-like breath odor); symptoms of infection (eg, fever, chills, cough, sore throat, increased or painful urination, increased pain or redness of injured or damaged skin); tremor; unusual bruising or bleeding.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of romidepsin:
Romidepsin is usually handled and stored by a health care provider. Keep romidepsin out of the reach of children and away from pets.
- If you have any questions about romidepsin, please talk with your doctor, pharmacist, or other health care provider.
- Romidepsin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take romidepsin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about romidepsin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to romidepsin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using romidepsin.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.